]]>On August 6, 2018, STADA Arzneimittel AG (“STADA”) announced that it had acquired a majority stake in BIOCEUTICALS Arzneimittel AG (“BIOCEUTICALS”). According to the press release, STADA is acquiring an additional 35.48 percent of the shares in BIOCEUTICALS from its co-shareholders to bring its total stake to 51.34 percent. BIOCEUTICALS licenses marketing rights to the epoetin biosimilar, epoetin zeta, to STADA and other companies. The press release notes that STADA markets the epoetin biosimilar, Silapo, in Germany. BIOCEUTICALS also licenses epoetin zeta to Hospira which sells it under the tradename Retacrit in various countries. As we reported here, Hospira was recently granted approval for Retacrit (epoetin alfa) in the United States.

]]>New BPCIA Litigation: AbbVie Files Suit on Sandoz’s HUMIRA (adalimumab) biosimilarhttps://www.bigmoleculewatch.com/2018/08/10/new-bpcia-litigation-abbvie-files-suit-on-sandozs-humira-adalimumab-biosimilar/
Sat, 11 Aug 2018 01:31:24 +0000https://www.bigmoleculewatch.com/?p=4586Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808...

]]>Today, AbbVie sued Sandoz regarding its proposed biosimilar to HUMIRA (adalimumab) in the District of New Jersey. The suit alleges infringement under the BPCIA of U.S. Patent Nos. 9,187,559 and 9,750,808. The ‘559 patent is directed to methods of administration of adalimumab for treatment of idiopathic inflammatory bowel diseases. The ‘808 patent is directed to formulations of adalimumab suitable for subcutaneous injection.

The complaint alleges that Sandoz notified AbbVie on January 12, 2018 that it had submitted an aBLA for an adalimumab biosimilar, which the FDA subsequently accepted on or before January 16, 2018. AbbVie further alleges the parties began exchanging information in January 2018, but according to AbbVie, Sandoz did not provide information in those exchanges on the process(es) used to manufacture its biosimilar, as required by (l)(2)(A).

The complaint goes on to allege that on March 18, 2018, AbbVie provided Sandoz with its list of potentially infringed patents under (l)(3)(A), which it supplemented under (l)(7) in April and May 2018 to add subsequently issued patents. The complaint states that Sandoz then provided its response under (l)(3)(B) and (l)(7)(B) that the patents AbbVie identified will not be infringed or are invalid. AbbVie states that it responded pursuant to (l)(3)(C) to Sandoz’s assertions as to 84 patents. The complaint further alleges that on August 5, 2018, Sandoz notified AbbVie it would agree to be sued on one patent. As the complaint states, the patent dance then provides that each party can identify one patent each to be litigated. The complaint alleges that “AbbVie will have a second opportunity, when Sandoz provides a 180-day Notice of Commercial Marketing (or as circumstances otherwise warrant), to assert its remaining patents.”

]]>Court Denies J&J’s Motion to Dismiss Pfizer’s Complaint in Antitrust Suithttps://www.bigmoleculewatch.com/2018/08/10/court-denies-jjs-motion-to-dismiss-pfizers-complaint-in-antitrust-suit/
Fri, 10 Aug 2018 22:23:11 +0000https://www.bigmoleculewatch.com/?p=4582As we reported here, Pfizer filed an antitrust lawsuit last year against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product since Pfizer introduced its competing biosimilar Inflectra (infliximab-dyyb) in 2016. As...

]]>As we reported here, Pfizer filed an antitrust lawsuit last year against Johnson & Johnson (J&J) in the U.S. District Court for the Eastern District of Pennsylvania alleging that J&J has engaged in an anticompetitive scheme to protect its Remicade® (infliximab) product since Pfizer introduced its competing biosimilar Inflectra (infliximab-dyyb) in 2016.

As we reported here, on November 18, 2017, J&J filed a motion to dismiss Pfizer’s complaint and on January 26, 2018, the Biosimilars Council filed an unopposed motion for leave to file an amicus curiae brief in opposition to J&J’s motion to dismiss.

On August 8, 2018, the Court denied J&J’s motion to dismiss, finding that Pfizer’s complaint sufficiently alleges that it has suffered an antitrust injury as the result of J&J’s anticompetitive conduct. The Court also denied the Biosimilars Council motion for leave.

]]>EMA’s CHMP Recommends Approval of Three Biosimilarshttps://www.bigmoleculewatch.com/2018/08/08/emas-chmp-recommends-approval-of-three-biosimilars/
Wed, 08 Aug 2018 17:01:19 +0000https://www.bigmoleculewatch.com/?p=4578The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s...

]]>The European Medicines Agency (EMA) recently published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) on July 23-26, 2018, reporting that CHMP had adopted positive opinions, recommending the granting of marketing authorisation, for three biosimilar medicines: (1) Fujifilm Kyowa Kirin Biologics (FKB) and Mylan’s Hulio (adalimumab), a biosimilar of Humira® for the treatment of certain inflammatory and autoimmune disorders; (2) Accord Healthcare’s Pelgraz (pegfilgrastim) and (3) Coherus Biosciences’ Udenyca (pegfilgrastim), both biosimilars of Neulasta® for the reduction of the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

In a joint press release, Mylan and FKB stated that “[t]he decision of the European Commission (EC) on the approval is expected in October 2018, which would grant marketing authorization in the 28 European Union (EU) member countries and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein” for Hulio. As we previously reported, Mylan and FKB are collaborating to commercialize this biosimilar in Europe.

Accord also issued a press release in conjunction with the CHMP’s positive opinion, stating that “[o]nce approved, Pelgraz could be the first pegfilgrastim biosimilar to market in Europe indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.” Quoting an Accord spokeperson, the press release further stated: “Our continued focus on bringing biopharmaceuticals to Europe has enabled us to be a first to launch a pegfilgrastim, and as a first mover we expect to gain an even bigger market share with Pelgraz.”

In addition, Coherus stated in a press release that “UDENYCA has the opportunity to become one of the first pegfilgrastim biosimilars to gain Marketing Authorization in Europe” and that “[t]he European Commission decision on the approval for UDENYCA is expected in October.” Coherus also noted that “UDENYCA is currently under evaluation by the U.S. Federal Drug Administration (FDA) with an action date expected on or before November 3, 2018.”

]]>New BPCIA Complaint: Amgen Sues Apotex, Again, over Proposed Pegfilgrastim and Filgrastim Biosimilarshttps://www.bigmoleculewatch.com/2018/08/07/new-bpcia-complaint-amgen-sues-apotex-again-over-proposed-pegfilgrastim-and-filgrastim-biosimilars/
Wed, 08 Aug 2018 00:23:23 +0000https://www.bigmoleculewatch.com/?p=4572Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars. The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to...

]]>Amgen filed a complaint against Apotex today in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 based on Apotex’s aBLAs for filgrastim and pegfilgrastim biosimilars.

The ’287 patent issued on January 2, 2018 and is directed to methods of protein refolding in non-mammalian expression systems. According to the complaint, the ‘287 patent issued after Amgen provided Apotex with lists of potentially infringed patents for both aBLAs during the patent dance pursuant to subsection (l)(3)(A), and pursuant to subsection (l)(7), Amgen supplemented its (l)(3)(A) lists with the ‘287 patent on January 31, 2018. The complaint further alleges that on March 2, 2018, Apotex in turn provided its statement pursuant to (l)(3)(B) of reasons why the ‘287 patent is invalid, unenforceable, and/or would not be infringed by its biosimilar product.

Amgen previously sued Apotex for infringement under the BPCIA of another protein folding patent based on these same aBLAs, but Amgen lost those suits last year when the Federal Circuit affirmed the district court’s judgments of non-infringement in favor of Apotex, as covered here.

The ‘287 patent is also being asserted by Amgen in its BPCIA litigation against Adello regarding its filgrastim aBLA.

]]>IGBA Urges FDA to Waive the Requirement for Bridging Studies for Biosimilar Sponsorshttps://www.bigmoleculewatch.com/2018/08/07/igba-urges-fda-to-waive-the-requirement-for-bridging-studies-for-biosimilar-sponsors/
Tue, 07 Aug 2018 16:38:17 +0000https://www.bigmoleculewatch.com/?p=4566In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required...

]]>In a letter to FDA last month, the International Generic and Biosimilar Medicines Association (IGBA), which represents member pharmaceutical companies from the USA, Canada, South Africa, India, Jordan, Japan, Europe and Taiwan, requested that FDA “revisit their position and waive the requirement of bridging studies.” Typically, biosimilar sponsors are required to justify the relevance of comparative data using a product approved by a foreign regulatory authority and establish an acceptable “bridge” to the US-licensed reference product. The necessity of such bridging studies is currently at the discretion of FDA. Arguing that the bridge between a US-licensed reference product and the non-US reference comparator can be established by the applicant “in most cases without bridging studies, while remaining within the regulatory biosimilars framework,” IGBA urged that FDA consider a new regulatory framework utilizing the concept of a “global comparator product” and, thus, avoiding the need for expensive repetition of studies across multiple comparator products in separate jurisdictions.

]]>NHS Announces Unexpected Increase in Savings from Switching to Biosimilarshttps://www.bigmoleculewatch.com/2018/08/06/nhs-announces-unexpected-increase-in-savings-from-switching-to-biosimilars/
Tue, 07 Aug 2018 01:10:53 +0000https://www.bigmoleculewatch.com/?p=4563The United Kingdom’s National Health Service (NHS) recently announced that in its last fiscal year, it had saved $419 million in switching to biosimilar and generic versions of ten expensive drugs. These savings exceeded the $324 million in savings the NHS had forecasted. According to the announcement, most of the...

]]>The United Kingdom’s National Health Service (NHS) recently announced that in its last fiscal year, it had saved $419 million in switching to biosimilar and generic versions of ten expensive drugs. These savings exceeded the $324 million in savings the NHS had forecasted. According to the announcement, most of the savings came from switching to biosimilars:

infliximab ($128 million)

imatinib ($85 million)

etanercept ($78 million)

rituximab ($65 million)

The NHS further noted that the drug it spends the most money on is adalimumab, which the NHS expects to be available as a biosimilar after October 2018. The NHS indicated that it expects to have even more savings this year from switching to biosimilars and generics.

]]>FDA Releases Biosimilar User Fee Act Rates for Fiscal Year 2019https://www.bigmoleculewatch.com/2018/08/02/fda-releases-biosimilar-user-fee-act-rates-for-fiscal-year-2019/
Fri, 03 Aug 2018 00:40:56 +0000https://www.bigmoleculewatch.com/?p=4559Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2019 fiscal year, which runs from October 1, 2018 through September 30, 2019. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other...

]]>Last week, FDA announced the Biosimilar User Fee Act (BsUFA) rates for the 2019 fiscal year, which runs from October 1, 2018 through September 30, 2019. The FDA determined these rates pursuant to the Food and Drug Administration Reauthorization Act (FDARA), signed into law on August 18, 2017. Among other things, FDARA reauthorized BsUFA through 2022.

The new rates for FY2019, compared with the rates for FY2018, are as follows:

]]>European Commission Grants Marketing Authorization for Adalimumab and Trastuzumab Biosimilarshttps://www.bigmoleculewatch.com/2018/08/02/european-commission-grants-marketing-authorization-for-adalimumab-and-trastuzumab-biosimilars/
Fri, 03 Aug 2018 00:37:53 +0000https://www.bigmoleculewatch.com/?p=4557Last week the European Commission granted marketing authorization for two biosimilars. First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira. Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis,...

]]>Last week the European Commission granted marketing authorization for two biosimilars.

First, Sandoz, a division of Novartis, announced on July 27 that it had received marketing authorization for Hyrimoz, its adalimumab biosimilar to AbbVie’s Humira. Authorization was granted for all indications of the reference biologic, including rheumatoid arthritis, plaque psoriasis, Crohn’s disease, uveitis, and ulcerative colitis. Sandoz’s Hyrimoz was shown to match the reference biologic in safety, efficacy, and technical quality. This is Sandoz’s seventh biosimilar approval in Europe. Approval from Hyrimoz also follows approval for four other adalimumab biosimilars in Europe: Amgevita and Solymbi by Amgen, Cyltezo by Boehringer Ingelheim, and Imraldi by Samsung Bioepis. Humira is currently the world’s highest selling drug, and reportedly generated approximately $18.4 billion in sales in 2017.

Second, on July 31, Pfizer announced that it had received marketing approval for Trazimera, its trastuzumab biosimilar to Roche/Genentech’s Herceptin. Trastuzumab treats breast and gastric cancers involving overexpression of the protein human epidermal growth factor (HER2). The approval was based on research that showed clinical equivalence between Trazimera and the reference product. This is Pfizer’s fourth biosimilar to receive approval in Europe and its first approval of an anticancer biosimilar. European patent protection for Herceptin expired in 2014, and Trazimera joins four other trastuzumab biosimilars that are currently on the market.

]]>AbbVie Raises Earnings Guidance and Reports Increased Humira Sales in Q2 Financial Reporthttps://www.bigmoleculewatch.com/2018/08/01/abbvie-raises-earnings-guidance-and-reports-increased-humira-sales-in-q2-financial-report/
Wed, 01 Aug 2018 21:37:54 +0000https://www.bigmoleculewatch.com/?p=4533AbbVie raised its 2018 earnings guidance last week, based in part on increased sales of Humira (adalimumab). In its report on its second-quarter 2018 financial results, AbbVie noted a 10% increase in U.S. sales of Humira in the quarter, and stated during the earnings call that it expected U.S. sales...

]]>AbbVie raised its 2018 earnings guidance last week, based in part on increased sales of Humira (adalimumab). In its report on its second-quarter 2018 financial results, AbbVie noted a 10% increase in U.S. sales of Humira in the quarter, and stated during the earnings call that it expected U.S. sales growth for Humira to be approximately 11% in the third quarter. On the earnings call, AbbVie’s CEO also discussed AbbVie’s patent portfolio on Humira and AbbVie’s various settlement agreements concerning biosimilar versions of Humira, stating, “[i]n the US we have patents with exp[i]ration dates well beyond 2030 and our earliest to expire IP is June, 2022. …. Given the breadth of the IP that we have and the overwhelming strength of the patents that we have, the license entry date represents what I would describe as a fairly negotiated license agreement[] that expedites biosimilar entry into the United States.”

As we’ve covered previously, AbbVie has entered patent license agreements with Amgen (whose biosimilar product Amjevita was approved in September 2016 and is permitted to launch in the U.S. on January 31, 2023 under the settlement agreement), Samsung Bioepis (who does not yet have an approved biosimilar adalimumab product in the U.S., and if approved is permitted to launch in the U.S. beginning on June 30, 2023), and, most recently, Mylan (who does not yet have an approved biosimilar adalimumab product in the U.S., and if approved is permitted to launch in the U.S. beginning on July 31, 2023).

Another biosimilar adalimumab product is still the subject of pending litigation: Boehringer Ingelheim’s Cyltezo product was approved in August 2017, and is the subject of an ongoing suit in which trial scheduling is slated to be discussed after the close of claim construction and fact and expert discovery (expert discovery is scheduled to close by May 29, 2020). And Sandoz, whose aBLA for its proposed adalimumab biosimilar product was accepted for FDA review in January 2018, has challenged several AbbVie patents on Humira in IPR proceedings (see here and here).